Choosing the right lateral flow test CMO; minimise risk and go with your instincts!
Why outsource your lateral flow manufacturing? It manages risk working with a lateral flow expert. It can be cost-effective. It may mean you don’t have to invest in both site and equipment and all the quality and regulatory aspects that come with it. At Abingdon we are passionate about supporting our customers through the process of outsourcing and truly believe it is a great solution for many; both from a financial and operational perspective.
It is important to work with a well-equipped partner that is in-tune with your test and business aspirations. So, what do you need to look for when choosing the right lateral flow test CMO (Contract Manufacturing Organisation) for you?
Questions to ask when choosing the right CMO
Do your due diligence. The selection process needs to result in choosing the right LFT manufacturer for your business for now and for the long-term. Do they have the right lateral flow expertise? Do they have a track record? Do they have the capability and bandwidth to transfer your test efficiently into production? However, the fundamental question is are they committed to making the client-CMO relationship a success?
The following list of questions helps you to start building a framework for you to determine whether you have identified the right CMO partner.
- Is contract manufacturing your CMO’s core proposition?
This is the most important question of all. Routine manufacturing requires a high level of expertise mixed with the right capacity, state-of-the-art automation, and established supply chains. So, you need to have confidence that your CMO has major focus in this area. For example, are they familiar with what is required when designing a robust lateral flow test specification for high-volume manufacture?
An experienced lateral flow manufacturer will have invested in the right people, processes, and infrastructure to ensure the successful routine production of quality lateral flow tests. This therefore acts as your safety net, mitigating risk for your test and your business.
- Does your CMO have a track record?
During the selection process the CMO should be able to show evidence of previous manufacturing projects. Ask them what types of lateral flow tests they have produced in the past, paying particular attention to processes, supply chains and automation, as well as volumes, batch success rates. For example, are batches delivered on-time-and-in-full (OTIF)? This all paints the picture of what you can expect from your prospective CMO.
- Is the CMO based in the right location to supply my markets efficiently?
Clients choose manufacturers for several reasons: with budgets and supply chain considerations being two of the major considerations. For example, those already outsourcing may want to switch to close-to-market production or onshore to speed-up supply or negate cost issues. Likewise, new outsourcers will be looking to minimise financial outgoings with a partner that help facilitate their markets cost-effectively and efficiently.
- Can your CMO scale-up your LFT manufacturing?
This question links directly to question 1. If manufacturing is one of your partner’s core activities, then scale-up and routine manufacture will be second nature. Whether it is switching from manual to automated production, increasing batch sizes, or moving your test out of R&D, experienced CMOs will make a big difference. The right infrastructure and people using tried and tested methods and processes, leads to time and cost efficiencies during scale-up: no trial and error, just doing the job right.
- Can your CMO support in other areas e.g., regulatory?
You always need to think about how you can leverage your partners expertise to help you hit key milestones. Any value-added services you can call upon will offer time and cost benefits by reducing the need to work more partners than necessary. At Abingdon Health we support our clients with navigating complex regulatory, legal, and commercial barriers. We know from feedback that our in-house regulatory know-how helps in making the regulatory process smoother. Also, by being an extension of our clients’ commercialisation activities we can support in accelerating commercial aspirations.
- Does your CMO have robust disaster recovery plans?
This has come to the forefront of many discussions we now have with contract customers. Disaster recovery and risk mitigation is a key issue. For example, is your CMO manufacturing on one site? What happens if there is a major COVID-19 outbreak or an issue with the site? Do they have a second source of manufacturing? Abingdon operates two manufacturing sites in York and Doncaster to give customers peace of mind. Established contingency planning mean we can adapt to various situations, switching manufacturing from one site to the other. Forward planning, supply chain and project management are a vital parts disaster recovery. Always be sure to ask which departments your partner will use to pre-empt any issues.
- Are they flexible and collaborative?
A CMO must support what works best for you. Therefore, a flexible and collaborate approach will enable you to meet demand in a way that meets your forecasts. Are they willing build output iteratively, as well as offer the ability to accelerate output to cope with spikes in demand or forecast increases? Will the CMO work with your current in-house or 3rd-party manufacturing or fulfilment solutions. After all, a CMO should be an extension of your team and work hard to meet your goals.
It is important to remember there is no ‘one-size-fits-all’ approach to outsourced manufacturing. After all, there are layered solutions to outsourced lateral flow test manufacturing in order to meet global demand.
Go With Your Instinct!
As mentioned, capacity, expertise, and manufacturing technology are important parts of any lateral flow test manufacturer. But a great attitude from your prospective partner will help you achieve your goals. Afterall, a CMO should live and breathe manufacturing, and be comfortable, and thrive on being an extension of your team. We advise that, if during your initial explorative calls and meetings with a prospective partner, you are met with approachable and enthusiastic team members, you have probably found the right partner for you.
Summary
The lateral flow test market across all industries will continue to grow, with competition being fierce, where ultimately, quality, and reliable supply will lead to the greatest market share. But getting to that point needs a combination of the right technology, planning, scheduling, but most importantly, the right people and business relationships! So, when choosing the right lateral flow test CMO for your organisation, clearly define what type of partner will help you hit your objectives effectively and on time.
About Abingdon Health
Whether you are experienced in outsourcing to CMOs or an emerging innovator, Abingdon Health thrives on working collaboratively and closely with our clients. We enthusiastically join our clients on their journey and impart LFT manufacturing and supply chain knowledge for the benefit of clients. Contact Abingdon Health to see how help you on your journey.
Download our manufacturing brochure.
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